Tissue AdhesionsNCT01819467
A Trial to Reduce Adhesions Following a Primary Cesarean Section
A study testing Seprafilm in people with Tissue Adhesions, run by South East Area Health Education Center, Wilmington, NC at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section. A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the… Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Tissue Adhesions
- What is being tested?
- Seprafilm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Females 12 years and older undergoing a scheduled primary cesarean section at or after 24 weeks estimated gestational period
Who cannot join
- Patients transferred from outlying hospitals who expect to undergo repeat C-section at that hospital.
- Patients who have had previous laparotomy
- Patients having a previous laparoscopy demonstrating adhesions of bladder peritoneum or uterine serosa or myometrium to the parietal peritoneum or omentum or bowel to the uterus or parietal peritoneum; or involving pelvic adhesiolysis, enterolysis or other surgery on bowel located in the pelvis, uterine myomectomy , adnexectomy or other adnexal surgery including ovarian cystectomy, tuboplasty, tubal reanastomosis, and removal of endometriosis
- Patients with an adhesion score > 0 at the time of primary cesarean section
- Patents with chorioamnionitis, appendicitis or infection of other pelvic viscera at the time of primary cesarean section.
- Patients who have taken systemic corticosteroids within 2 weeks of the primary cesarean section. Provided however, patients who have been treated with systemic betamethasone or dexamethasone to promote fetal lung maturity are not excluded
Show all 11Show fewer
- Patients undergoing tubal sterilization at the time of the primary cesarean section
- Patients with known allergy to hyaluronic acid
- The following criteria are seen as complications or adverse events experienced by the patients in the interval after the puerperium and will therefore exclude patients:
- Patient who have had a pelvic inflammatory disease documented by either cervical motion, uterine or adnexal tenderness; and either oral temperature > 101 degrees or mucopurulent cervical discharge or cervical culture positive for C. trachomatis or N. Gonorrhoeae
- Patients who have pelvic abscess or diverticulitis
Trial locations and contacts
1 site in 1 country.
United States1 site
New Hanover Regional Medical Center
Wilmington, North Carolina, 28401
About this study
Official title: A Randomized Controlled Trial to Reduce Adhesions Following a Primary Cesarean Section
The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section.
A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the infant exists.
Read the detailed description
A cesarean section or delivery (C-section/CD) is the surgical removal of an infant and placenta through the mother's abdominal and uterine wall. This procedure is performed by an obstetrician and is one of the most common types of surgical methods used today. According to the Centers for Disease Control and Prevention, the rate for this method of delivery has risen over the past decade. However, recent research has shown that patients who receive this surgical procedure become more susceptible to adhesions.
Adhesions are formations (bands) of scar tissue that occur immediately following most surgical procedures. Adhesions limit the mobility of tissues and organs near the incision site by causing them to stick together. This limited mobility can generate an increased rate of morbidity (occurrence of other diseases). Morbidities caused by adhesions include but are not limited to abdominal and/or pelvic pain, bowel obstruction (partial or complete blockage of the bowel), subfertility (difficulty getting pregnant) and infertility (inability to get pregnant).
A study conducted by Dierdre Lyell, MD reported that the incidence of adhesion formation following a primary CD ranges from 46-65%. Another study (Morales et al) reported that for women who had undergone a CD, the incidence rate of adhesions and severe adhesions was greater in women who had had repeat CDs compared with women who only had a primary CD. In addition, this study also states that the percentage of adhesion occurrence increases in women with each subsequent (following) CD.
Numerous methods have been implemented toward the preventions of adhesions. Currently, Seprafilm is an approved adhesion prevention method that is used in most surgical procedures. Seprafilm is a clear film that is composed of chemically modified sugars (some of which occur naturally in the human body). Unlike its counterpart Interceed, Seprafilm is unaffected by the presence of blood. After being placed, Seprafilm becomes a gel within 24-48 hours and then is slowly absorbed and excreted by the body over the course of 1-4 weeks.
Seprafilm Adhesion Barrier is FDA approved for use in patients undergoing abdominal or pelvis laparotomy as an adjunct intended to reduce the incidence, extent and severity of post-operative adhesions between the abdominal and between the uterus and surrounding structures.
- Conditions
- Tissue Adhesions
- Being tested
- Seprafilm
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeprafilmDevice
Seprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | Patients in this group will receive Seprafilm onto the uterine incision and the anterior midline of the uterus. Receives: Device: Seprafilm |
| Control Group | No intervention | This arm will be known as the control/no intervention group. This group will not receive Seprafilm or any other adhesion barrier method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion Formation Following a Primary C-section With and Without Adhesion Barrier
Study was terminated due to too many protocol deviations. There were no outcome measures analyzed.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startJun 2014
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Slow to accrue, lack of qualified participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tissue AdhesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- South East Area Health Education Center, Wilmington, NC
- Sponsor type
- University, hospital or other
- Collaborators
- New Hanover Regional Medical Center
- Responsible party
- Principal investigator, Todd Beste, South East Area Health Education Center, Wilmington, NC
- Investigators
- Henry A Easley, MD, Principal investigator, South East Area Health Education Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819467
- Sponsor's protocol ID
- 1301-1
- Status last verified
- Jul 2023
- First submitted
- 18 Mar 2013
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Morales KJ, Gordon MC, Bates GW Jr. Postcesarean delivery adhesions associated with delayed delivery of infant. Am J Obstet Gynecol. 2007 May;196(5):461.e1-6. doi: 10.1016/j.ajog.2006.12.017.
PubMed 17466702Lyell DJ. Adhesions and perioperative complications of repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S11-8. doi: 10.1016/j.ajog.2011.09.029. Epub 2011 Oct 6.
PubMed 22114993
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Reduce Adhesions Following a Primary Cesarean Section
- ClinicalTrials.gov ID
- NCT01819467
- Acronym / sponsor ID
- 1301-1
- Conditions
- Tissue Adhesions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow to accrue, lack of qualified participants
- Enrolment
- 29 participants (actual)
- Lead sponsor
- South East Area Health Education Center, Wilmington, NCUniversity, hospital or other
- Collaborators
- New Hanover Regional Medical Center
- Study start
- Jun 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine whether the use of Seprafilm reduces the incidence rate of adhesion formation following a primary C-section.
A secondary objective of the study will be to determine whether or not a correlation between the adhesion score and the difficulty or delay in delivery of the infant exists.
Detailed description
A cesarean section or delivery (C-section/CD) is the surgical removal of an infant and placenta through the mother's abdominal and uterine wall. This procedure is performed by an obstetrician and is one of the most common types of surgical methods used today. According to the Centers for Disease Control and Prevention, the rate for this method of delivery has risen over the past decade. However, recent research has shown that patients who receive this surgical procedure become more susceptible to adhesions.
Adhesions are formations (bands) of scar tissue that occur immediately following most surgical procedures. Adhesions limit the mobility of tissues and organs near the incision site by causing them to stick together. This limited mobility can generate an increased rate of morbidity (occurrence of other diseases). Morbidities caused by adhesions include but are not limited to abdominal and/or pelvic pain, bowel obstruction (partial or complete blockage of the bowel), subfertility (difficulty getting pregnant) and infertility (inability to get pregnant).
A study conducted by Dierdre Lyell, MD reported that the incidence of adhesion formation following a primary CD ranges from 46-65%. Another study (Morales et al) reported that for women who had undergone a CD, the incidence rate of adhesions and severe adhesions was greater in women who had had repeat CDs compared with women who only had a primary CD. In addition, this study also states that the percentage of adhesion occurrence increases in women with each subsequent (following) CD.
Numerous methods have been implemented toward the preventions of adhesions. Currently, Seprafilm is an approved adhesion prevention method that is used in most surgical procedures. Seprafilm is a clear film that is composed of chemically modified sugars (some of which occur naturally in the human body). Unlike its counterpart Interceed, Seprafilm is unaffected by the presence of blood. After being placed, Seprafilm becomes a gel within 24-48 hours and then is slowly absorbed and excreted by the body over the course of 1-4 weeks.
Seprafilm Adhesion Barrier is FDA approved for use in patients undergoing abdominal or pelvis laparotomy as an adjunct intended to reduce the incidence, extent and severity of post-operative adhesions between the abdominal and between the uterus and surrounding structures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Device: SeprafilmPatients in this group will receive Seprafilm onto the uterine incision and the anterior midline of the uterus. |
| Control Group | No intervention | –This arm will be known as the control/no intervention group. This group will not receive Seprafilm or any other adhesion barrier method |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Females 12 years and older undergoing a scheduled primary cesarean section at or after 24 weeks estimated gestational period
Key exclusion criteria (11 listed)
- Patients transferred from outlying hospitals who expect to undergo repeat C-section at that hospital.
- Patients who have had previous laparotomy
- Patients having a previous laparoscopy demonstrating adhesions of bladder peritoneum or uterine serosa or myometrium to the parietal peritoneum or omentum or bowel to the uterus or parietal peritoneum; or involving pelvic adhesiolysis, enterolysis or other surgery on bowel located in the pelvis, uterine myomectomy , adnexectomy or other adnexal surgery including ovarian cystectomy, tuboplasty, tubal reanastomosis, and removal of endometriosis
- Patients with an adhesion score > 0 at the time of primary cesarean section
- Patents with chorioamnionitis, appendicitis or infection of other pelvic viscera at the time of primary cesarean section.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeprafilmSeprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section | Device | Treatment Group |
Primary outcome
Adhesion Formation Following a Primary C-section With and Without Adhesion Barrier
Time frame: 21 months
Study was terminated due to too many protocol deviations. There were no outcome measures analyzed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17466702Morales KJ, Gordon MC, Bates GW Jr. Postcesarean delivery adhesions associated with delayed delivery of infant. Am J Obstet Gynecol. 2007 May;196(5):461.e1-6. doi: 10.1016/j.ajog.2006.12.017.
- Background: PubMed 22114993Lyell DJ. Adhesions and perioperative complications of repeat cesarean delivery. Am J Obstet Gynecol. 2011 Dec;205(6 Suppl):S11-8. doi: 10.1016/j.ajog.2011.09.029. Epub 2011 Oct 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry A Easley, MD principal investigator
South East Area Health Education Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seprafilm in people with Tissue Adhesions, run by South East Area Health Education Center, Wilmington, NC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion Formation Following a Primary C-section With and Without Adhesion Barrier (time frame: 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819467, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.